保健食品批文延续和相关资料要求等

Health Food CFDA Registration Certificate Renewal

1. What is health food renewal?

Health food renewal, means CFDA administrative bureau accordance with the application, and based on lawful procedure, matters and requirements, apply for the extend health food approval certificate expiry date.

2. Who can apply for the renewal?

The applicant should be the holder of the approval certificate.

3. When apply for the renewal application?

Need to extend the health food approval certificate before the expiry date, and applicant should apply for the renewal three months before the expiry date.

4. What is the renewal procedure of the health food?

(1) Domestic health food renewal process:

(2) Abroad products renewal process:

5. What documents needed to be provided on health food renewal?（1）Domestic products

1. Domestic health food renewal application form.

2. Copies of applicant’s ID, business license or other legal registration confirmation certificate from other bureaus.

3. Copy of health food approval certificate confirmation documents (including health food approval certificate and health food changing approval certificate).

4. Copy of products manufacture and tianjianhuacheng sales confirmation certificate issued by health food manufacture administrative bureau in province.

5. Conclusion of sales situation in five years.

6. Conclusion of the products feedbacks in five years.

7. Health food minimum sales package, label and instruction.

Note 1：If cannot provide complete documents above, applicant should give explanation in written during certificate renewal.

Note 2：The above copies should have the seals from holder of the original certificate.

（2）Imported Products

1. Application form of imported health food renewal.

2. If abroad company allow resident offices of foreign to do the

renewal business, it should provide the copy of the “registration certificate of resident offices in China of foreign enterprises”; if abroad company entrusts agency in China to deal with renewal business, it should provide the original tianjianhuacheng copy of power of attorney and the copy of business license of the agency.

3. Copy of health food approval certificate (including health food approval certificate and its attachment and health food changing approval certificate).

4. Manufacture country (or region) related authorities issued GMP and allow the products free sales confirmation certificate, and this confirmation must be notarized by notary public and local Chinese embassy in country (region).

5. Conclusion of Chinese imported, sales situations in five years.

6. Conclusion of Chinese composition feedbacks in five years.

7. Health food minimum sales package, labels and instructions.

Note 1：The above copies should have seals of the holder of the original certificate.

Note 2：If cannot provide any of above documents, it should apply in written and give explanation.